Medisystem Negative Pressure
FDA 510(k) K811839 · Medisystems Corp.
510(k) numberK811839
Submission
- Device name
- Medisystem Negative Pressure
- Applicant
- Medisystems Corp.
Mchenry, IL, US - Received
- July 1, 1981
- Decision date
- September 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 05/15/2026SE |
| K251341 | VITAL Tubing Sets for HemodialysisFJK · Traditional | Vital Healthcare Sdn. Bhd. | 01/16/2026SE |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 10/02/2025SE |
| K243607 | Moda-flx Hemodialysis System Cartridge (102121-001 )FJK · Special | Diality, Inc. | 12/20/2024SE |
| K213992 | CombiSet Hemodialysis Blood Tubing SetFJK · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2023SE |
| K210782 | Tablo CartridgeFJK · Traditional | Outset Medical, Inc. | 11/26/2021SE |
| K202796 | SANSIN Tubing Sets for HemodialysisFJK · Traditional | Jiangxi Sanxin Medtec Co., Ltd. | 09/06/2021SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 03/10/2021SE |
| K171952 | Dimesol Tubing Sets for HemodialysisFJK · Traditional | Dimesol, Inc. | 03/30/2018SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/16/2017SE |
More from Bain Medical Equipment (Guangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceFIE · Traditional | 02/12/2007SE |
| K010279 | Medisystems Luer Access Injection SiteFPA · Traditional | 05/29/2001SE |
| K002372 | Access Alert GaugeKOC · Traditional | 10/25/2000SE |
| K994306 | ReversoKOC · Traditional | 03/20/2000SE |
| K990803 | Medisystems Buttonhole Needle SetsFIE · Traditional | 01/06/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | 11/25/1998SE |
| K971860 | Medisystems Dialysis Priming SetsKOC · Traditional | 08/18/1997SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | 08/15/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | 05/12/1997SE |
| K953823 | Arterial Venous Blood Tubing SetFJK · Traditional | 09/23/1996SE |
Questions and answers
When was Medisystem Negative Pressure cleared by the FDA?
Medisystem Negative Pressure (K811839) received a 510(k) decision of Substantially Equivalent on September 8, 1981, 69 days after the submission was received.
What is the product code of K811839?
The FDA product code is FJK – Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a Class II (moderate risk) device regulated under 21 CFR 876.5820.